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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4KO ARTHROSCOPE DV AC 4X70X160MM RND TI

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SMITH & NEPHEW, INC. 4KO ARTHROSCOPE DV AC 4X70X160MM RND TI Back to Search Results
Catalog Number 72205155
Device Problems Crack (1135); Optical Obstruction (3002)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4). The reported device, intended for use in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident.  a visual inspection found distal tip and fiber damage, broken lenses, and a cracked distal lens. A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.  a complaint history review concluded this was an isolated event. The complaint was confirmed. Factors that could have contributed to the reported event include an impact event inconsistent with normal use. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that during the set up inspection, the scope was found blurry. Backup device was available to complete the procedure. No significant delay and no patient injuries were reported. Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name4KO ARTHROSCOPE DV AC 4X70X160MM RND TI
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11496521
MDR Text Key241813837
Report Number3003604053-2021-00092
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72205155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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